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Proton Radiation Therapy for Gliomas

Primary Purpose

Low Grade Glioma, WHO Grade 3 Glioma With IDH1 Mutation, WHO Grade 3 Glioma With 1p/19q Codeletion

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton radiation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Grade Glioma focused on measuring Brain tumors, Radiation, Proton, Gliomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed low-grade gliomas OR Grade III anaplastic glioma with either or both IDH1 mutation or 1p/19q codeletion
  • Subject must be indicated for radiation therapy
  • Life expectancy greater than 5 years
  • Willing to participate in rigorous neurocognitive evaluations at baseline and serially following treatment
  • Able to speak and comprehend English
  • Recovered from adverse events due to agents administered more than 4 weeks before entering study
  • Able to undergo MRI scans

Exclusion Criteria:

  • Prior cranial radiation therapy
  • Chemotherapy within 4 weeks prior to entering study
  • Pregnant or breastfeeding
  • Known brain metastases
  • Baseline neurocognitive or emotional disorders
  • Uncontrolled intercurrent illness
  • History of a different malignancy unless disease-free for at least 5 years
  • HIV positive on antiretroviral therapy

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton radiation therapy

Arm Description

Single arm study delivering fractionated proton therapy over 6 week (54-59.4 Gy(RBE))

Outcomes

Primary Outcome Measures

Efficacy
To assess progression free survival of this treatment program.

Secondary Outcome Measures

Safety and Tolerability
To assess the number of participants with late effects from radiation therapy
Overall survival
To assess overall survival of this treatment program.

Full Information

First Posted
May 17, 2011
Last Updated
August 17, 2020
Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01358058
Brief Title
Proton Radiation Therapy for Gliomas
Official Title
Phase II Study of Proton Radiation Therapy for Low Grade and Favorable Grade 3 Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this research study the investigators are looking at a type of radiation called proton radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects that patients would normally experience with conventional radiation therapy. In this research study the investigators are looking to determine if proton radiation with a reduced field size will be as effective in controlling tumor growth as photon therapy, while reducing the treatment-related side effects observed in patients with brain tumors.
Detailed Description
Proton radiation will be delivered daily for approximately 6 weeks. Subjects will be assessed weekly for side effects. Each visit will take about 15 minutes. Subjects will have follow-up visits at 3, 6, 12, 24, 36, 48, 60, 72, and 84 months after their last proton radiation treatment. They will receive a physical exam, MRI, have blood tests (about 4 teaspoons) and answer questionnaires regarding medical history, quality of life, and emotional well-being. Subjects will also receive a neurocognitive exam annually.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Grade Glioma, WHO Grade 3 Glioma With IDH1 Mutation, WHO Grade 3 Glioma With 1p/19q Codeletion
Keywords
Brain tumors, Radiation, Proton, Gliomas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proton radiation therapy
Arm Type
Experimental
Arm Description
Single arm study delivering fractionated proton therapy over 6 week (54-59.4 Gy(RBE))
Intervention Type
Radiation
Intervention Name(s)
Proton radiation
Intervention Description
Total dose of 54-59.4 Gy(RBE) at 1.8 Gy(RBE) per daily fraction delivered 5 days per week on weekdays for 6-6.5 weeks.
Primary Outcome Measure Information:
Title
Efficacy
Description
To assess progression free survival of this treatment program.
Time Frame
7 years
Secondary Outcome Measure Information:
Title
Safety and Tolerability
Description
To assess the number of participants with late effects from radiation therapy
Time Frame
7 years
Title
Overall survival
Description
To assess overall survival of this treatment program.
Time Frame
7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed low-grade gliomas OR Grade III anaplastic glioma with either or both IDH1 mutation or 1p/19q codeletion Subject must be indicated for radiation therapy Life expectancy greater than 5 years Willing to participate in rigorous neurocognitive evaluations at baseline and serially following treatment Able to speak and comprehend English Recovered from adverse events due to agents administered more than 4 weeks before entering study Able to undergo MRI scans Exclusion Criteria: Prior cranial radiation therapy Chemotherapy within 4 weeks prior to entering study Pregnant or breastfeeding Known brain metastases Baseline neurocognitive or emotional disorders Uncontrolled intercurrent illness History of a different malignancy unless disease-free for at least 5 years HIV positive on antiretroviral therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen A Shih, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Proton Radiation Therapy for Gliomas

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